Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT03252951
Eligibility Criteria:
Inclusion Criteria:
* AI based on FISI questionnaire
* FISI scores between 10 and 45
* able to voluntarily contract pelvic floor muscles based on manometry measures
Exclusion Criteria:
* FISI score below 10 (mild disease) or greater than 45 (severe disease)
* manometry measure below the 10th percentile of normal (lack of muscle) or above 70th percentile of normal (little room to improve strength)
* history of large external hemorrhoids or history of bleeding hemorrhoids; co-existing inflammatory bowel disease
* constipation that is directly linked to neurological conditions such as spinal and peripheral nerve pathologies
* large pelvic organ prolapse (greater than stage 3)
* inability to contract the pelvic floor muscles on command
* pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
22 Years
Study:
NCT03252951
Study Brief:
Protocol Section:
NCT03252951